Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610851
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-30
Brief Title:
Monitoring of Patients With Low-grade Gliomas Using Circulating miRNA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Monitoring of Patients With Low-grade Gliomas Using Circulating miRNA
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GLIBAMIR
Brief Summary:
With around 3400 cases per year in France diffuse gliomas are the most common primary tumours of the central nervous system Their grade varies from 2 to 4 Whatever the grade their prognosis is poor because tumour recurrence is systematic because no personalised medicine is available for the treatment of these cancers and because the tools for monitoring recurrence are imperfect Treatment of diffuse gliomas is based on removal of as much of the tumour as possible whatever its grade Surgery is followed by radiotherapy and chemotherapy depending on the grade and quality of the excision In the event of recurrence the patient may be offered second-line chemotherapy or further surgery During and after treatment patients are regularly monitored by MRI in order to detect any recurrence as early as possible and propose a new treatment However for grade 2 and 3 gliomas MRI monitoring is imperfect because it cannot detect tumour recurrence at an early stage Initiation of new treatment at the time of recurrence which is inevitable is therefore often delayed which is harmful for patients
It is therefore vital to identify a reliable easy-to-use and non-invasive biomarker that can be used to monitor patients undergoing surgery for grade 2 and 3 diffuse gliomas and thus enable earlier diagnosis of recurrence These biomarkers could be microRNAs
MicroRNAs are small non-coding RNAs involved in the regulation of genes and consequently of the intracellular signalling pathways that govern cell behaviour They are therefore widely implicated in oncogenesis and in particular in the mechanisms that promote tumour migration invasion and proliferation
Several preliminary studies have shown that serum levels of pro-oncogenic microRNAs correlate with tumour rates in gliomas No study has investigated the possibility of using them to detect tumour recurrence earlier in grade 2 and 3 gliomas
With this study the investigators hope to use pro-oncogenic microRNAs to monitor glioma patients and diagnose early recurrence in grade 2 and 3 gliomas
It is therefore vital to identify a reliable easy-to-use and non-invasive biomarker that can be used to monitor patients undergoing surgery for grade 2 and 3 diffuse gliomas and thus enable earlier diagnosis of recurrence These biomarkers could be microRNAs
MicroRNAs are small non-coding RNAs involved in the regulation of genes and consequently of the intracellular signalling pathways that govern cell behaviour They are therefore widely implicated in oncogenesis and in particular in the mechanisms that promote tumour migration invasion and proliferation
Several preliminary studies have shown that serum levels of pro-oncogenic microRNAs correlate with tumour rates in gliomas No study has investigated the possibility of using them to detect tumour recurrence earlier in grade 2 and 3 gliomas
With this study the investigators hope to use pro-oncogenic microRNAs to monitor glioma patients and diagnose early recurrence in grade 2 and 3 gliomas
Detailed Description:
Diffuse gliomas are the most common primary tumours of the central nervous system representing around 3400 cases per year in France Defossez et al 2019 Their grade varies from 2 to 4 Whatever the grade their prognosis is poor Grade 2 median survival 10 years Grade 3 median survival around 5 years Grade 4 median survival 2 years Yang et al 2016
Grade 2 and 3 diffuse gliomas are rarer than Grade 4 gliomas and their treatment is based on removing the tumour as completely as possible while preserving the patients neurological function This surgical treatment is sometimes followed by chemotherapy andor radiotherapy depending on the grade of the tumour and the quality of the excision Recurrence of grade 2 and 3 gliomas after surgery is systematic and generally occurs within 2 to 5 years of surgery Pineda et al 2023 Gliomas are infiltrating tumours in which tumour cells are found infiltrating the cerebral parenchyma up to 2 cm from the periphery of the tumour as seen on MRI which explains their inevitable recurrence since surgery cannot be wide it is difficult to create safety margins in the brain and will invariably leave tumour cells in situ Pallud et al 2013
In the event of recurrence the patient may be offered second-line chemotherapy or further surgery
Patients are monitored for recurrence by regular brain MRI but this is imperfect because it is difficult to detect tumour recurrence which appears as a slow increase in the FLAIR hypersignal If there is any doubt about a recurrence MRI is repeated 2 to 3 months later to clearly identify the recurrence This confirmation wastes time in the management of patients who are treated too late
To improve the diagnosis of recurrence in these patients it is vital to identify a reliable easy-to-use and non-invasive biomarker for monitoring patients undergoing surgery for diffuse glioma MicroRNAs could be the tool sorely lacking in the monitoring of glioma patients
MicroRNAs are small non-coding RNAs involved in the post-transcriptional regulation of genes and consequently of the intracellular signalling pathways that govern cell behaviour Komatsu et al 2023 They are widely implicated in oncogenesis and in particular in the mechanisms promoting cell migration invasion and proliferation Romano et al 2021
Several preliminary studies have shown that the serum level of pro-oncogenic microRNAs correlates with the tumour rate in gliomas Jones et al 2021 Levallet et al 2022 Morokoff et al 2020 Morokoffs study showed encouraging but insufficient results on the possibility of using microRNAs to diagnose recurrence in grade 2 and 3 gliomas These results need to be consolidated prospectively using homogeneous samples from all patients
MAIN OBJECTIVE
To describe the time course of plasma levels of pro-oncogenic microRNAs after surgery for grade 2 or 3 glioma in order to assess whether they can detect recurrence earlier than MRI The investigators hope to identify microRNAs with
a stable profile in subjects without recurrence
a change in their levels in the event of recurrence
SECONDARY OBJECTIVES
1 To assess the correlation between
1 tumour and plasma levels at Day 0 for each microRNA
2 the tumour levels at D0 of the microRNAs in pairs
3 plasma levels at Day 0 and Day 4 of paired microRNAs
2 Assess the correlation between tumour volume at D0 and
1 tumour rate at Day 0 for each microRNA
2 plasma levels at Day 0 and Day 4 for each microRNA
3 Assess the relationship between plasma levels of each microRNA at Day 0 and Day 4 and recurrence-free survival
4 To assess the relationship between tumour levels at Day 0 of each microRNA and recurrence-free survival
PIONEERING NATURE Most research projects aimed at improving the follow-up of gliomas are based on improving imaging parameters perfusion sequences PET-MRI These examinations are often difficult to access with appointment times delaying treatment Diagnosis of recurrence depends on the radiologist In addition not all teams are trained in perfusion analysis and nuclear medicine teams are rare in France
The investigator are proposing here an original approach blood sampling innovative microRNA assay and above all simple to be used routinely to improve the follow-up of these patients
Grade 2 and 3 diffuse gliomas are rarer than Grade 4 gliomas and their treatment is based on removing the tumour as completely as possible while preserving the patients neurological function This surgical treatment is sometimes followed by chemotherapy andor radiotherapy depending on the grade of the tumour and the quality of the excision Recurrence of grade 2 and 3 gliomas after surgery is systematic and generally occurs within 2 to 5 years of surgery Pineda et al 2023 Gliomas are infiltrating tumours in which tumour cells are found infiltrating the cerebral parenchyma up to 2 cm from the periphery of the tumour as seen on MRI which explains their inevitable recurrence since surgery cannot be wide it is difficult to create safety margins in the brain and will invariably leave tumour cells in situ Pallud et al 2013
In the event of recurrence the patient may be offered second-line chemotherapy or further surgery
Patients are monitored for recurrence by regular brain MRI but this is imperfect because it is difficult to detect tumour recurrence which appears as a slow increase in the FLAIR hypersignal If there is any doubt about a recurrence MRI is repeated 2 to 3 months later to clearly identify the recurrence This confirmation wastes time in the management of patients who are treated too late
To improve the diagnosis of recurrence in these patients it is vital to identify a reliable easy-to-use and non-invasive biomarker for monitoring patients undergoing surgery for diffuse glioma MicroRNAs could be the tool sorely lacking in the monitoring of glioma patients
MicroRNAs are small non-coding RNAs involved in the post-transcriptional regulation of genes and consequently of the intracellular signalling pathways that govern cell behaviour Komatsu et al 2023 They are widely implicated in oncogenesis and in particular in the mechanisms promoting cell migration invasion and proliferation Romano et al 2021
Several preliminary studies have shown that the serum level of pro-oncogenic microRNAs correlates with the tumour rate in gliomas Jones et al 2021 Levallet et al 2022 Morokoff et al 2020 Morokoffs study showed encouraging but insufficient results on the possibility of using microRNAs to diagnose recurrence in grade 2 and 3 gliomas These results need to be consolidated prospectively using homogeneous samples from all patients
MAIN OBJECTIVE
To describe the time course of plasma levels of pro-oncogenic microRNAs after surgery for grade 2 or 3 glioma in order to assess whether they can detect recurrence earlier than MRI The investigators hope to identify microRNAs with
a stable profile in subjects without recurrence
a change in their levels in the event of recurrence
SECONDARY OBJECTIVES
1 To assess the correlation between
1 tumour and plasma levels at Day 0 for each microRNA
2 the tumour levels at D0 of the microRNAs in pairs
3 plasma levels at Day 0 and Day 4 of paired microRNAs
2 Assess the correlation between tumour volume at D0 and
1 tumour rate at Day 0 for each microRNA
2 plasma levels at Day 0 and Day 4 for each microRNA
3 Assess the relationship between plasma levels of each microRNA at Day 0 and Day 4 and recurrence-free survival
4 To assess the relationship between tumour levels at Day 0 of each microRNA and recurrence-free survival
PIONEERING NATURE Most research projects aimed at improving the follow-up of gliomas are based on improving imaging parameters perfusion sequences PET-MRI These examinations are often difficult to access with appointment times delaying treatment Diagnosis of recurrence depends on the radiologist In addition not all teams are trained in perfusion analysis and nuclear medicine teams are rare in France
The investigator are proposing here an original approach blood sampling innovative microRNA assay and above all simple to be used routinely to improve the follow-up of these patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None